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Heart Rate Variability Biofeedback for Smoking Cessation (HRVB-SCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03972137
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Intervention Feasibility: Participant Attendance and Adherence [ Time Frame: Weekly from Week 1 through Week 7 ]
    A composite index of attendance and adherence (e.g., homework completion) will be used to index intervention feasibility, from Week 1 through Week 7 (i.e., end-of-treatment).
  • Intervention Feasibility, Treatment Initiation: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 1 ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon treatment initiation.
  • Intervention Feasibility, End-of Treatment: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 7, i.e., end-of-treatment ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon completing the intervention.
  • Intervention Acceptability, Treatment Initiation: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 1 ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon treatment initiation.
  • Intervention Acceptability, End-of-Treatment: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 7, i.e., end-of-treatment ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon completing the intervention at Week 7.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • Changes in Smoking Rate [ Time Frame: Week 0 (i.e., baseline), Week 3 (i.e., quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Change in smoking behavior from Week 0 (i.e., baseline) through Week 16 (i.e., 3-months post-quit) will be assessed via the well established Timeline Followback calendar interview.
  • Smoking Cessation [ Time Frame: Week 3 (i.e, Quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Smoking cessation will be based upon self-report and carbon monoxide analysis of breath sample (<5 ppm) at Week 3, i.e., the quit date, and at Week 5, Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit date. Participants whose abstinence is verified via carbon monoxide analysis of breath at Week 16, which occurs approximately five weeks following transdermal nicotine patch termination for those who use the full 8-week course, will provide a saliva sample for cotinine testing to biologically verify abstinence (<12 ng/mL). Participants whose carbon monoxide analysis of breath sample (I.e., Weeks 3, 5, and 7) or cotinine analysis (Week 16) do not indicate abstinence will be coded as smoking.
  • Change in Total Emotional Distress [ Time Frame: Week 0, Week 5, Week 7, Week 16, i.e., baseline, 2-weeks, 1-month, and 3-months post-quit ]
    Self-reported changes, over time, in total emotional distress will be evaluated via the 21-item, Depression, Anxiety and Stress Scale from Week 0 (i.e., baseline) to Week 5 Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit. Items will be rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability Biofeedback for Smoking Cessation
Official Title  ICMJE Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
Brief Summary Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling plus transdermal nicotine replacement patch in smokers with elevated emotional distress.
Detailed Description The investigators propose to develop and pilot test heart rate variability biofeedback for smokers with elevated emotional distress as an adjunct to individual smoking cessation counseling and transdermal nicotine patch. In this open trial, all participants will receive the active intervention. Findings will be used to refine the protocol in advance of a subsequent Phase III randomized clinical trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will be assigned to individualized smoking cessation, nicotine replacement therapy patch, and heart rate variability biofeedback.
Masking: None (Open Label)
Masking Description:
This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Primary Purpose: Treatment
Condition  ICMJE Tobacco Smoking
Intervention  ICMJE
  • Behavioral: Cognitiive-Behaivoral Smoking Cessation
    Participants will be provided with five individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.
    Other Names:
    • Cognitive-behavioral therapy
    • Smoking cessation counseling
  • Behavioral: Heart Rate Variability Biofeedback
    Heart Rate Variability Biofeedback: All participants will be provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
    Other Names:
    • Biofeedback
    • Respiratory biofeedback
  • Drug: Nicotine patch
    All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
    Other Names:
    • Transdermal nicotine patch
    • Nicotine replacement therapy
Study Arms  ICMJE Experimental: HRVB-SCT
All participants in this open trial will receive individualized cognitive-behavioral smoking cessation treatment, up to 8 weeks of the transdermal nicotine patch, and individualized heart rate variability biofeedback.
Interventions:
  • Behavioral: Cognitiive-Behaivoral Smoking Cessation
  • Behavioral: Heart Rate Variability Biofeedback
  • Drug: Nicotine patch
Publications * Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Smoking ≥5 cigarettes, daily, for at least two years
  • expired carbon monoxide analysis of breath sample ≥8 ppm
  • elevated affective distress
  • motivation to quit
  • computer proficient

Exclusion Criteria:

  • current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention for smoking cessation
  • endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
  • inability to provide written informed consent
  • current evidence of another substance use disorder
  • severe visual or hearing impairments
  • self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
  • self-reported medical issues of potential concern to nicotine patch users
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Teresa M Leyro, Ph.D. 732-659-4283 teresa.leyro@rutgers.edu
Contact: Mindy Kibbey 732-659-4283 mmk192@scarletmail.rutgers.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972137
Other Study ID Numbers  ICMJE 2018001848
R34DA043751 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We currently have no plans to share individual participant data from this small open trial as it will be used to guide refinement of a subsequent larger randomized controlled trial.
Responsible Party Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP